To assess the safety and tolerability, characterize the dose-limiting toxicities, and identify the maximum tolerated dose of BMS-986016 alone and in combination with Nivolumab in subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide preliminary information on the clinical benefits of the combination.

Safety as measured by the rate of AEs, serious AEs, deaths and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4) [ Time Frame: Approximately Up to 2.3 years (96 weeks of treatment period and 135 days of follow-up) ] [ Designated as safety issue: Yes ]

CTCAE = Common Terminology Criteria for Adverse Events (AEs);

AEs = Adverse events;

SAEs = Serious adverse events

Secondary Outcome Measures:

Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 14 time points up to Cycle 12 (approximately 96 weeks) ] [ Designated as safety issue: No ]

Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 14 time points up to Cycle 12 (approximately 96 weeks) ] [ Designated as safety issue: No ]

Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

AUC = area under the concentration-time curve

Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 2 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

DF - Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: 15 time points up through part of Cycle 3 (approximately 18 weeks) ] [ Designated as safety issue: No ]

Efficacy as measured by tumor assessment (irRECIST and RECIST) [ Time Frame: Every 8 weeks during treatment period (up to twelve 8-week cycles), and once during clinical follow-up period (30 days), for a total of approximately 1.9 years ] [ Designated as safety issue: No ]

Part C Cohort Expansion: Advanced (metastatic and/or unresectable) and incurable: melanoma (naive to ICMARs and progressing while on- or after receiving anti-CTLA-4 and anti-PD-1 or anti-PD-L1 therapy); melanoma subjects last dose of anti-CTLA 4 therapy must be ≥ 100 days before receiving study drug medication ; non-small cell lung cancer (NSCLC) (naive to ICMARs and progressing while on- or after anti-PD-1 or anti-PD-L1 as most recent therapy) head and neck squamous cell carcinomas; or gastric adenocarcinoma naive to ICMARs

Part A: Progressed, or been intolerant to, at least one standard treatment regimen in the advanced or metastatic setting (if such a therapy exists)

Part B or C: Progressed, or been intolerant to, at least one standard treatment regimen or refuse standard treatment in the advanced or metastatic setting (if such therapy exists)

Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease

Uncontrolled CNS metastases

Any prior exposure to immune cell modulating antibody regimens except as described in inclusion criteria for Part B subjects or specific Part C subjects

Autoimmune disease

Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01968109

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: